MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; SCREW, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Blood Loss (2597); No Code Available (3191)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: koehler s., et al (2016), autologous bone graft versus pekk cage for vertebral replacement after 1- or 2-level anterior median corpectomy, j neurosurg spine, volume 24, pages 309¿314 (germany).This study aims to analyze the clinical and radiological outcomes of patients with an autologous bone graft or a pekk cage for vertebral replacement after accf of the cervical spine.Between 2004 and 2012, a total of 137 underwent a 1- or 2-level accf.Out of these, 46 patients (28 male and 18 female) mean age 67 ± 10 years, were included in the study.19 patients (group 1) underwent vertebral replacement with an autologous iliac graft and, 27 patients (group 2) received a peek cage implant.All of the patients also underwent osteosynthesis with an anterior plate-screw system (cervical spine locking plate [cslp] system, synthes).The mean follow-up times were 19.2 ± 15.2 months [group 1] and 21.9 ± 13.6 months [group 2].The following complications were reported as follows: significant rebleeding into the cervical soft tissue, leading to early revision surgery, occurred in 2 (4.3%) patients, 1 in each group.One patient in group 2 required early revision surgery as a result of csf leakage.1 case of an anterior revision procedure followed by posterior instrumentation was performed because of persistent pain and failed bony fusion.1 patient did not achieve osseous fusion at the end of the follow-up.2 patients did not achieve osseous fusion at the end of the follow-up.4 cases of implant -related complication ( implant site) the mean reported pain vas scores at the end of follow- up had improved significantly (p < 0.01) over those reported in the preoperative assessments in group 1 (from 2.26 ± 1.79 to 1.11 ± 0.99) group 2 (from 2.63 ± 1.63 to 1.19 ± 0.88).In group 2, the mean relative height of the implants increased, which suggests that the implants impressed the adjacent vertebrae and their endplates.The mean loss of height in group 1 was caused by impaction of the bony implant, as depicted by the mean decrease of the relative height of the implant-related to the total height of the spondylodesis.Anterior revision of the pekk cage and plate¿screw system was performed after 3 and 4 months, respectively.In group 2, a minor dislocation of the plate-screw system in 1 patient was recorded.Cage and loosening of the plate-screw system with a new neurological deficit and/or intractable pain made revision surgery necessary.1 patient had a minor loosening of the screws occurred, but revision surgery was not needed.This report is for unknown synthes screws.This is report 2 of 5 for complaint (b)(4).It captures the reported adverse events of significant rebleeding, csf leak, surgical intervention, pain, nonunion, adjacent segment degeneration and medical device removal.

• Brand Name: UNK - SCREWS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9009891
• MDR Text Key: 161794547
• Report Number: 8030965-2019-68218
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention